Efficacy and tolerability of moxifloxacin in patients with sinusitis treated in general practice : results of a post-marketing surveillance study.

OBJECTIVE: To assess the efficacy, safety and tolerability of moxifloxacin, an 8-methoxy fluoroquinolone, in patients with respiratory tract infections (RTIs) treated in general practice in Germany. Different RTIs were analysed separately, and this paper focuses on patients with acute sinusitis. METHODS, DESIGN AND PATIENTS: This was an open-label, prospective, uncontrolled, post-marketing surveillance study undertaken between October 2001 and June 2002. Symptoms of sinusitis (fever, cough, nasal obstruction, nasal secretion and headache) were assessed at baseline and at follow-up visits, and classified as 'absent', 'mild' or 'severe' by the attending physician. RESULTS: Altogether 9036 patients were treated with moxifloxacin, of whom 2405 adult men and women had sinusitis. Sinusitis symptoms were improved or cured in at least 92% of patients. Moxifloxacin produced significant improvements after only 3 days (71.6% of patients); 96.2% of patients were improved after 5 days. Most patients (89.5%) had recovered by day 8 and 97.3% by day 10. Physicians rated moxifloxacin therapy as 'good' or 'very good' in 96.6% of patients and almost all favoured prescribing moxifloxacin in the future. Very few adverse events were reported with moxifloxacin (<0.4%), and were mostly gastrointestinal disturbances. CONCLUSIONS: Moxifloxacin is a very effective and safe treatment for patients with acute sinusitis in general practice and is highly regarded by both physicians and patients because of rapid symptom improvement and good tolerability.

[Current therapeutical management, new antibiotics and treatment of Pseudomonas aeruginosa in bacterial ENT-infections]. / Anmerkungen zu aktuellen Therapiestrategien, neuen Antibiotika und Pseudomonas aeruginosa bei bakteriellen HNO-Infektionen.

In bacterial infections of the sinuses and the middle ear Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis and Staphylococcus aureus are most frequently isolated, whereas in tonsillopharyngitis Streptococcus pyogenes is the most important pathogen. S. aureus is found in up to 40 % in acute and chronic sinusitis and causes severe complications in otitis media, therefore antibiotics used as empirical initial treatment should also be effective against this pathogen. To decrease duration of illness and to avoid serious complications antibiotic treatment of bacterial ENT-infections is necessary. The new ketolides and the third and fourth generation quinolones are very effective and the second generation cephalosporins like cefuroxime axetil have proven excellent clinical and bacteriological efficacy in numerous clinical trials combined with an excellent resistance pattern over the years. Efficacy of short course therapy (5 days) in sinusitis and tonsillopharyngitis has been proven in clinical trials and is cost saving. In more severe infections treated in hospital sequential i. v./oral therapy offers pharmaco-economical benefits. Both regimen demonstrate cost savings while maintaining high clinical efficacy. In more severe infections like otitis externa diffusa, otitis externa maligna, otitis media chronica and perichondritis Pseudomonas aeruginosa is a dangerous pathogen that has to be covered by initial antibiotic treatment. Ciprofloxacin and Ceftazidime are widely used and effective. Ciprofloxacin resistance has increased, while Ceftazidime susceptibility is unchanged (> 90 %). A dose reduction study with ceftazidime in severe ENT-infections showed equivocal efficacy between 3 x 1 g and 3 x 2 g daily that offers a cost benefit of 50 %.

Grepafloxacin: a review of its safety profile based on clinical trials and postmarketing surveillance.

The safety profile of grepafloxacin has been characterized in a number of preclinical and clinical studies. Preclinical investigations have shown that its toxicologic profile is similar to that of other fluoroquinolones, and phase I studies in humans have confirmed these data. A photosensitivity study demonstrated equivalence with ciprofloxacin, and a study in elderly patients taking the highest clinical dose of grepafloxacin indicated that prolongation of the QTc interval by grepafloxacin was less than 2 ms, 15 times less than that observed in a study of erythromycin. In phase II and III clinical investigations conducted in the United States and the United Kingdom, safety data have been gathered from more than 3000 patients with either community-acquired pneumonia or acute bacterial exacerbations of chronic bronchitis. The most common adverse events with grepafloxacin 400 or 600 mg were gastrointestinal, such as nausea, vomiting, and diarrhea. The frequency of these adverse events was similar to that seen with ciprofloxacin. Significantly more patients reported a mild, unpleasant metallic taste with grepafloxacin than with ciprofloxacin, but <1% of patients withdrew from therapy because of this. Headache was observed significantly more often in ciprofloxacin-treated patients than in grepafloxacin-treated patients. Recent postmarketing data confirm the good tolerability and safety profile of grepafloxacin. These data, from a case-report study of more than 9000 patients in Germany, demonstrated that only 2.3% of patients reported adverse events when grepafloxacin was used in routine clinical practice. The most frequently reported events were nausea (0.8%) and gastrointestinal symptoms (0.4%). Dizziness was reported by only 0.3% of patients, and only 4 patients (0.04%) reported photosensitization. Adverse events did not appear to be either dose dependent or related to diagnosis. More than 400,000 patients world-wide have received grepafloxacin treatment. No new safety issues have arisen from the spontaneous-report data and, with the exception of rare reports of an unpleasant taste, the most commonly reported events have been the same as those seen in clinical studies. These data support grepafloxacin as a well-tolerated fluoroquinolone suitable for the treatment of community-acquired respiratory tract infections.

[Recurrent laryngeal nerve paralysis after thyroid gland operations. Etiology and consequences]. / Recurrenslähmungen nach Schilddrüsenoperationen. Ursachen und Konsequenzen.

In the period of 1 January 1990 to 31 December 1996 the thyroidectomy cases we performed were immediately followed by vocal cord evaluation using a flexible bronchoscope while the patient was still on the operating table. If an obvious cord paralysis was discovered, an exploration of the recurrent laryngeal nerve, to the level of the larynx, was performed. If the nerve was found to be intact, no further measures were taken. A severed nerve underwent suture repair. If an otolaryngologist diagnosed a vocal cord paralysis 1-5 days after surgery, a reoperation was recommended except in the cases where postoperative bronchoscopy had shown an easily mobile cord or the recurrent nerve was completely dissected during the operation. Within this 7-year period, we performed 3492 thyroidectomy operations. The diagnosis of subsequent unilateral postoperative vocal cord paralysis occurred in 48 cases. In 33 of these cases the status of the nerve in the surgical field was known: 4 patients had an intact nerve proved by complete dissection during thyroidectomy, in two patients the lesions of the nerve were detected intraoperatively (1 transsection, 1 partial resection), and 27 cases were followed by reoperation. Of the 33 patients mentioned above, in 19 instances the recurrent laryngeal nerve was found to be intact; 3 displayed signs of local trauma, and 11 were found to be severed with total discontinuity. Those patients with an intact nerve, or local nerve trauma only, went on to develop normal function within 6 months in 20 (91%) of 22 cases. Of the 11 with a severed nerve, 8 showed "autoparalysis" with good voice within 4-8 months, after suture repair in 10 cases. The patient with partial resection had no repair of the nerve. If immediate postoperative evaluation showed mobility of the vocal cords but a paralysis was detected later by an otolaryngologist and repeat intervention was not done, vocal cord function was spontaneously restored in 9 of 11 patients. Four patients refused reoperation. From 1990 to 1991, the recurrent laryngeal nerve was not always dissected during our thyroidectomy operations. However, this was done routinely from 1991 to 1996. Routine intraoperative dissection of the vocal cord nerve reduced the rate of postoperative cord paralysis from 2.0% to 1.2%. It also reduced the frequency of intraoperative nerve injury with total discontinuity from 0.58% to 0.23%.

An international medico-economic survey of 2007 children with recurrent nasopharyngitis and acute otitis media. Preliminary bindings.

The terminology used to describe upper respiratory tract infections (URTIs) in children can be based on the symptomatic picture, the aetiological agents or anatomical features involved, or classical disease descriptions. However, there is a lack of precision in the epidemiology and nosology of nasopharyngitis and acute otitis media (AOM) in children. Moreover, there are differences between European countries in diagnostic and therapeutic measures. The aim of this broad survey was to record all items potentially relating to URTIs in children and, therefore, to refine the classification of nasopharyngitis and AOM, as well as to clearly define their medical and economic consequences as observed in normal medical practice. Specifically, the objectives can be summarised as follows: to define nasopharyngitis as a clear-cut entity and thus provide a standard for clinical trials; to identify different definitions of AOM and compare them with Paradise's algorithm; to establish a profile of patients at risk of recurrences; to assess therapeutic habits; and to determine the cost of illness. The survey involved 328 European physicians (general practitioners, paediatricians, ear, nose and throat specialists), who recorded spontaneous medical visits of 2007 children presenting with a first episode of nasopharyngitis or AOM during November and December 1996. These children were then followed up until April 1997 so that any recurrent episodes could be recorded. A parent questionnaire focusing on burden of illness for the family was also included. Demographic characteristics at inclusion and the first data on the multifactorial correspondence analysis for nasopharyngitis at inclusion are available and have been presented.

[Diagnosis and therapy of thromboses of the internal jugular vein]. / Diagnostik und Therapie bei Thrombosen der Vena Jugularis Interna.

The etiology of internal jugular vein thrombosis has changed over to non-inflammatory causes. The advancement in non-invasive diagnostic methods often allows a very early diagnosis. The usual operative therapy is completed by new conservative methods. The authors report about the changed etiology, newer diagnostic methods and actual therapies of the disease.

[Possibilities and limits of reconstructive surgery of the recurrent laryngeal nerve]. / Möglichkeiten und Grenzen der rekonstruktiven Chirurgie des N. recurrens.

The authors report on possibilities and borderlines of reconstructive microsurgery of the recurrent laryngeal nerve. When paralysis of the vocal cord is proved after thyreoidectomy exploration and control of the nerve should be done immediately. This must be done as fast as possible, latest at the 7th day after thyreoidectomy. If there is found nerve injury caused by intraneural hematoma or compressing sutures microneurosurgical neurolysis and decompression can be done very successful. 8 of 10 neurolysis of the recurrent laryngeal nerve reported by the authors were successful. Because of consecutive autoparalysis nerve suture is possible but not effective.

[The accuracy of plain-film radiology in demonstrating the shadows of the pneumatic spaces of the skull--a comparison with computed tomography]. / Treffsicherheit der Nativradiologie im Nachweis von Verschattungen der pneumatisierten Räume des Schädels--Vergleich mit der Computertomographie.

The accuracy of plain-film radiography in the diagnosis of opacities of the pneumatic system of the skull was evaluated in 302 patients in comparison with computed tomography. Plain films were performed using standard projections (Schüller, Stenvers, NNH o.n., paranasal sinus). Concerning the paranasal sinuses sensitivity of plain film radiography ranged from 36.7 to 66.4% depending on localisation. In the mastoid, a sensitivity of only 35% was found. Specificity was high (90% and over) with the exception of the maxillary sinus (82%). More sensitive, noninvasive diagnostic imaging techniques are indicated in the following conditions: therapy-refractory opacification of one sinus, indeterminate otological symptoms in the presence of a low pneumatized mastoid, and definitive exclusion of infectious foci in the pneumatic system of the skull.

[The computed tomography of malignant otitis externa]. / Computertomographie der malignen Otitis externa.

Computed tomography was performed preoperatively in 20 patients suffering from malignant external otitis. The CT findings were nearly completely confirmed by the intraoperative findings. A circumscribed or diffuse thickening of the cartilaginous wall of the external auditory canal and an inflammatory infiltration of the subtemporal fossa are, in combination, most suspicious signs of malignant external otitis. Computed tomography enables detailed information on the extension of the pneumatic system and the grade of involvement of bones and soft tissues in malignant external otitis. A modified classification of malignant external otitis based on computed tomographic findings is proposed.

[Early complications following stapedectomy--surgical or conservative treatment?]. / Frühkomplikationen nach Stapedektomie--operative oder konservative Behandlung?

The incidence of sensorineural hearing loss after stapedectomy ranges from 0.6% to 5%. There is evidence that reparative granuloma is a major cause: most authors report that it requires urgent surgery, but this view is not universally accepted. This study analyses 14 stapedectomies that resulted in a sudden or gradual sensorineural hearing loss, often combined with vertigo, and presenting between 1 and 6 weeks after an initial hearing improvement. All patients were treated immediately with a combined infusion of an antibiotic, a corticosteroid and a plasma expander. The sensorineural hearing loss began to improve compared with pre-operative values 9 days later. Thus drug therapy might be sufficient in most cases of sensorineural hearing loss early after stapedectomy, and surgery can be restricted to patients with perilymph fistulae.

[Indications and technic of transoral dens resection in craniocervical dysplasia]. / Indikation und Technik der transoralen Densresektion bei kraniozervikaler Dysplasie.

Compressive lesions of the brain stem caused by ventrally or dorsally located bony malformations of the posterior skull base and the upper cervical spine show diffuse neurological signs and symptoms. They can imitate multiple sclerosis, cerebellar tumours, Ménière's disease and "Ménière-like" otological symptoms. Therefore, the otologist is involved in diagnosis and therapy of cranio-cervical dysplasia. At present dysplasia is differentiated into an anterior and posterior form of the disease. The most common lesion in the anterior form is brain stem compression by the high located dens axis. Therefore, transoral surgical removal of the dislocated odontoid process is the logical form of treatment and should be performed in patients with severe complaints. The technique used for the transoral resection of the odontoid process is described in detail. In 7 patients having the anterior type of the cranio-cervical dysplasia we performed a transoral resection of the elevated odontoid process. The results obtained were convincing with all patients. No intraoperative or postoperative complications were seen. Hearing impairment was not changed, neurological deficits and particularly vertigo improved. Follow-up examinations did not show any disturbances of head movements or remarkable dislocations of the kraniozervikal joints.

[Therapy of herpes simplex and varicella zoster infections in the ENT area]. / Zur Therapie von Herpes-simplex- und Varicella-zoster-Infektionen im HNO-Bereich.

The article reports on 41 patients having infections induced by Herpes simplex and Herpes zoster virus. Systemic intravenous administration of acyclovir results in a very rapid reduction of pain and mucosal changes in herpetic stomatitis. In cutaneous lesions of the trigeminal nerve branches induced by Herpes zoster virus there is also a very rapid reduction of pain and efflurescence after 3 days. In 16 patients suffering from Ramsay Hunt syndrome, also known as Herpes zoster oticus, lesions of the facial nerve function were present. 8 Patients demonstrated cochleovestibular signs and symptoms, 2 had flat inner ear hearing loss of 40 dB, 1 reduced unilateral caloric response. Treatment was effected by intravenous administration of acyclovir and simultaneous classical symptomatic therapy consisting of intravenously administered dextrane, cortisone and antiinflammatory drugs. Symptomatic therapy is necessary because acyclovir stops the replication of viruses but does not influence the disturbed nerve function. In 2 cases with a damage of more than 90% of the facial nerve fibres, endaural decompression of the geniculate ganglion was performed. Cochleovestibular deficits improved to normal during one week and all facial lesions within 8 months. Drug-related side effects were seen in one patient who had an exanthema.